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European Medicines Agency (EMEA) Approves ALIMTA® (pemetrexed For Injection) For Use In Lung Cancer Treatment

Published
Monday 14 April 2008 Published Mon 14 Apr 2008

By Peter M Crosta

On
April 11, 2008, an announcement by Eli Lilly and Company (NYSE:
LLY) indicated that European health authorities have approved the
use of ALIMTA® (pemetrexed for injection) for a histologically-based
use in the first-line treatment of advanced non-small-cell lung cancer
(NSCLC), the most common form of lung cancer. This is the
third approval that pemetrexed has received in Europe, and
it comes after the European Medicines Agency's (EMEA)
Committee
for
Medicinal Products for Human Use (CHMP) had issued a positive opinion
in mid-February. The act will allow all 27 countries of the European
Union, Norway,
Iceland, and Liechtenstein to use the therapy.

Richard Gaynor, M.D. (VP of cancer research and leader of Lilly's
global oncology platform) said, "This approval opens the door for a
novel, tailored approach based on
histology or tissue type. Our
hope is that this study provides physicians with a powerful tool for
choosing the right drug for the right patient that leads to optimal
treatment results."

Currently, more than 85 countries allow pemetrexed in combination with
cisplatin to treat malignant pleural
mesothelioma (MPM) when the disease is unresectable or when curative
surgery is infeasible. Countries also allow pemetrexed to be used as a
second-line, single agent treatment for patients with locally
advanced or metastatic NSCLC after chemotherapy. This most recent
approval allows the drug to be used as a first-line treatment for
patients with NSCLC who have other than predominantly
squamous cell histology.

More than 1 million people die from lung cancer every year, and 85 to
90 percent of all lung cancers are NSCLC.[3, 5] Categorized by five
stages, NSCLC starts at stage 0 and rises to the level of
severe at stage IV.[4] The disease can spread
through the lymphatic system, penetrating the chest lining, ribs, and
the nerves and blood vessels that lead to the arm. If cancerous cells
get into the bloodstream, additional potential targets include the
liver, bones
and brain.

The EMEA's approval is explicitly for
pemetrexed combined with cisplatin
as a first-line treatment for NSCLC patients who have a cell histology
that is not predominantly squamous. NSCLC is categorized according to
its histology (the microscopic
study of tissue), and in the past all histologies were treated
similarly.

When survival was analyzed by histology in a
pre-planned histological analysis, participants that had either
adenocarcinoma or large-cell carcinoma and were treated with the
pemetrexed
regimen in the first-line setting showed an improvement that was
clinically relevant in overall survival. Patients with squamous cell
histology, however, demonstrated better overall
survival when treated with the gemcitabine regimen.

Lead investigator Giorgio Scagliotti, M.D. (Department of Clinical and
Biological Sciences Thoracic Oncology Unit,
University of Torino, Orbassano, Italy) stated that this approval is an
important milestone
in the quest to treat the cancer that is the leading cause of death in
the world. He said, "This study provides further evidence of the need
to use a tailored
approach to treating lung cancer patients, rather than simply using a
particular medicine because of the treatment stage."

About Lilly Oncology, a Division of Eli Lilly and Company

For more than four decades, Lilly Oncology has been collaborating with
cancer researchers to deliver innovative treatment choices and valuable
programs to patients and their physicians. Inspired by courageous
patients living with cancer, Lilly Oncology is providing treatments
that are considered global standards of care and developing a broad
portfolio of novel targeted therapies to accelerate the pace and
progress of cancer care.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products
by applying the latest research from its own worldwide laboratories and
from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers - through
medicines and information - for some of the world's most urgent medical
needs.

ALIMTA® (pemetrexed for injection), Lilly

GEMZAR® (gemcitabine HCl for injection), Lilly

This press release contains forward-looking statements about the
potential of ALIMTA and GEMZAR for the treatment of non-small cell lung
cancer and reflects Lilly's current beliefs. However, as with
any
pharmaceutical product under development, there are substantial risks
and uncertainties in the process of development, commercialization, and
regulatory review. There is no guarantee that the product
will receive
additional regulatory approvals. There is also no guarantee that the
product will continue to be commercially successful. For
further
discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange
Commission.
Lilly undertakes no duty to update forward-looking statements.

Important Safety Information for ALIMTA

Myelosuppression is usually the dose-limiting toxicity with ALIMTA
therapy.

Contraindication

ALIMTA is contraindicated in patients who have a history of severe
hypersensitivity reaction to pemetrexed or to any other ingredient used
in the formulation.

Warnings

ALIMTA should not be administered to patients with a creatinine
clearance folic acid and
vitamin B12 died of drug-related toxicity following administration of
ALIMTA alone.

Patients must be instructed to take folic acid and vitamin B12 with
ALIMTA as a prophylaxis to reduce treatment-related hematologic and GI
toxicities.

Pregnancy Category D-ALIMTA may cause fetal harm when administered to a
pregnant woman.

Precautions

Complete blood cell counts, including platelet counts and periodic
chemistry tests, should be performed on all patients receiving ALIMTA.

Patients should not begin a new cycle of treatment unless the ANC is ³
1500 cells/mm3 and the platelet count is ³ 100,000 cells/mm3 and
creatinine clearance is ³ 45 mL/min.

Pretreatment with dexamethasone or its equivalent has been reported to
reduce the incidence and severity of skin rash.

The effect of third space fluid, such as pleural effusion and ascites,
on ALIMTA is unknown.

In patients with clinically significant third space fluid,
consideration should be given to draining the effusion prior to ALIMTA
administration.

Concomitant administration of nephrotoxic drugs or substances that are
tubularly secreted could result in delayed clearance of ALIMTA.

Caution should be used when administering ibuprofen concurrently with
ALIMTA to patients with mild to moderate renal insufficiency
(creatinine clearance from 45 to 79 mL/min). Patients with mild to
moderate renal insufficiency should avoid taking NSAIDs with short
elimination half-lives for a period of 2 days before, the day of, and 2
days following administration of ALIMTA. In the absence of data
regarding potential interaction between ALIMTA and NSAIDs with longer
half-lives, all patients taking these NSAIDs should interrupt dosing
for at least 5 days before, the day of, and 2 days following ALIMTA
administration. If concomitant administration of an NSAID is necessary,
patients should be monitored closely for toxicity, especially
myelosuppression, renal and gastrointestinal toxicities.

It is recommended that nursing be discontinued if the mother is being
treated with ALIMTA.

ALIMTA should be administered under the supervision of a qualified
physician experienced in the use of antineoplastic agents.

Dose adjustments may be necessary in patients with hepatic
insufficiency.

Dosing and Modification Guidelines

Dose adjustments at the start of a subsequent cycle should be based on
nadir hematologic counts or maximum nonhematologic toxicity from the
preceding cycle of therapy. Modify or suspend therapy according to the
Dosage Reduction Guidelines in the full Prescribing Information.

See complete Warnings, Precautions, Adverse Reactions, and Dosage and
Administration sections in the full Prescribing Information for safety
and dosing guidelines.

Important Safety Information for GEMZAR

Myelosuppression is usually the dose-limiting toxicity with GEMZAR
therapy.

Contraindication

Known hypersensitivity to GEMZAR.

Warnings

Infusion times of GEMZAR longer than 60 minutes and more frequent than
weekly dosing have been shown to increase toxicity.

Pulmonary toxicity has been reported. In cases of severe lung toxicity,
GEMZAR therapy should be discontinued immediately and appropriate
supportive care measures instituted.

Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported
following one or more doses of GEMZAR. Renal failure leading to death
or requiring dialysis, despite discontinuation of therapy, has been
rarely reported. The majority of the cases of renal failure leading to
death were due to HUS.

Serious hepatotoxicity, including liver failure and death, has been
reported very rarely in patients receiving GEMZAR alone or in
combination with other potentially hepatotoxic drugs.

GEMZAR is Pregnancy Category D. GEMZAR can cause fetal harm when
administered to a pregnant woman.

Precautions

Use caution in patients with pre-existing renal impairment or hepatic
insufficiency. Administration of GEMZAR may exacerbate underlying
hepatic insufficiency.

The optimum regimen for safe administration of GEMZAR with therapeutic
doses of radiation has not yet been determined in all tumor types.
GEMZAR has radiosensitizing activity and radiation recall reactions
have been reported.

It is not known whether GEMZAR or its metabolites are excreted in human
milk.

The effectiveness of GEMZAR in pediatric patients has not been
demonstrated.

The toxicities of GEMZAR observed in pediatric patients were similar to
those reported in adults.

GEMZAR clearance is affected by age as well as gender.

Patients receiving therapy with GEMZAR should be monitored closely by a
physician experienced in the use of cancer chemotherapeutic agents.

Patients should be assessed with a CBC, including differential and
platelet count, prior to each dose of GEMZAR. Modify or suspend therapy
according to the Dosage Reduction Guidelines in the full Prescribing
Information.

Hepatic and renal function (including transaminases and serum
creatinine) should be evaluated prior to therapy with GEMZAR and
periodically thereafter.

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